BioXcel announces FDA acceptance of sNDA for IGALMI in at-home agitation; PDUFA Nov 14, 2026

BioXcel Therapeutics, Inc.

FDA accepted supplemental New Drug Application for IGALMI (dexmedetomidine) for acute agitation in bipolar disorders or schizophrenia in outpatient setting.
PDUFA target action date is November 14, 2026.
If approved, IGALMI would be the first sublingual film for at-home agitation treatment.

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